A Study to Evaluate the Safety and Efficacy(Immunogenicity) of GC3114 in Healthy Adults

Randomized, Single-Blind, Active Comparator-controlled Study to Evaluate the Safety and Immunological Efficacy of GC3114 in Healthy Adults.

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT03357263

Enrollment

Registered

2017-11-29

Start date

2017-11-20

Completion date

2017-12-22

Last updated

2018-11-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Influenza, Human

Brief summary

Healthy adults will be once administered GC3114A(High-dose Quadrivalent influenza vaccine) or GCFLU Quadrivalent Pre-filled syringe inj..

Detailed description

Healthy adults will be once administered GC3114A(High-dose Quadrivalent influenza vaccine) or GCFLU Quadrivalent Pre-filled syringe inj.. Safety and immunological efficacy will be evaluated.

Interventions

BIOLOGICALGC3114

High-dose Quadrivalent influenza vaccine

BIOLOGICALGCFLU Quadrivalent

Quadrivalent influenza vaccine

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

PREVENTION

Masking

SINGLE (Subject)

Eligibility

Sex/Gender

ALL

Age

19 Years to 64 Years

Healthy volunteers

Yes

Inclusion criteria

* Healthy adults aged 19-64 years old * Informed consent form has been signed and dated * Able to comply with the requirements of the study

Exclusion criteria

* Known systemic hypersensitive to eggs, chicken proteins, or any of the vaccine components * Personal history of Guillain-Barre syndrome(GBS) * Subjects with severe chronic disease who are considered by investigator to be ineligible for the study * Subjects who received a vaccination within 28 days before enrollment or who are scheduled for another vaccination during the study * Immunocompromised subjects with immunodeficiency disease or subjects receiving immunosuppressive or immunomodulating therapy * Pregnant or lactating women

Design outcomes

Primary

Measure	Time frame	Description
Adverse Event	for 7 days from Day0/during study period	Solicited/Unsolicited Adverse Event

Secondary

Measure	Time frame	Description
Percentage of participants achieving pre-defined Seroconversion Before and following vaccination	Day 0 and Day 21	Seroconversion rate (SCR)
Percentage of participants achieving pre-defined Seroprotection Before and following vaccination	Day 0 and Day 21	Seroprotection rate (SPR)
Geometric Mean Titer and Geometric Mean Titer Ratios of Antibodies to the Investigational Product Before and Following vaccination	Day 0 and Day 21	Geometric Mean Titer(GMT), Geometric Mean Titer(GMT)

Countries

South Korea

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 2, 2026